A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
Aperçu de l'étude
Description détaillée
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total duration of accrual is approximately 24 months, with all patients expected to complete all protocol treatment and imaging within a further 3 months. The trial will close after the last patient has completed his/her last protocol related follow-up visit (at 12 months post-treatment).
Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of the dose (D99=100%). It is anticipated that most treatments should be highly conformal. Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed within 3 weeks or concurrently with respect to the investigational treatment. Consultation with the treating radiation oncologist is strongly recommended if chemotherapy is to be considered after the investigational treatment and before documented disease progression, to prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from this recommendation.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Victoria
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East Melbourne, Victoria, Australie, 3002
- Peter MacCallum Cancer Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age > 18 years old
All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
- Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or
- Cohort 2: single adrenal metastases with extra-adrenal disease controlled
- ECOG performance of 0-2 inclusive.
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Informed consent.
Exclusion Criteria:
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
- Previous high-dose radiotherapy to upper abdomen
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Radiotherapy
The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size. For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size. For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The number of patients who complete prescribed treatment.
Délai: After 24 months
|
This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
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After 24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Toxicity of SBRT in study patients measured using CTCAE V4.0
Délai: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
|
Specific toxicities will include, but are not limited to;
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Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
|
|
Efficacy of stereotactic radiosurgery
Délai: 1 year after treatment
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Effective SBRT is defined as a treatment which results in local control at 1 year after treatment.
Local control is defined as lack of progression of the target lesion as measured by RECIST criteria.
RECIST criteria are a CT evaluation of change in tumour size.
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1 year after treatment
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Feasibility of using Diffusion weighted-MRI for response assessment.
Délai: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
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At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shankar Siva, Peter MacCallum Cancer Centre, Australia
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11/106
- U1111-1132-5574 (Identificateur de registre: ANZCTR)
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